Job title:
QA Specialist
Job statement:
As a QA Specialist, you will play a critical role in implementing and maintaining the company quality management system (QMS) to ensure compliance with relevant regulatory standards and guidelines, such as ISO 13485 and FDA regulations.
Location: Santa Barbara, CA (On-site required)
About us
Aptitude Medical Systems is a startup deep-tech healthcare company. Our mission is democratizing diagnostics by empowering individuals to access their health and diagnostic information anytime, anywhere. Aptitude created a simple, accurate, and easy-to-use diagnostic platform that fits in the palm of the hand and allows anyone to run a complex lab-quality PCR test in their own hands in minutes. Aptitude’s lead products, Metrix™ COVID-19 Test and COVID/Flu Test, are FDA-authorized molecular diagnostic tests to work with swab samples for at-home and over-the-counter use without physician supervision, and we have a product pipeline that includes tests fora wide range of health and wellness conditions.
Imagine being able to consult your doctor, run the diagnostic tests you need, and get a prescription without having to leave your home. That's the future we're building. Come join us!
About the role
We are seeking a meticulous and knowledgeable Medical Device Quality Assurance (QA) Specialist to ensure the safety, efficacy, and compliance of our medical device products. The QA Specialist will play a critical role in implementing and maintaining quality management systems, conducting thorough testing procedures, and adhering to regulatory requirements. The ideal candidate will have a strong background in medical device QA, excellent attention to detail, and a commitment to upholding the highest standards of quality and safety in healthcare.The work location for this position is Santa Barbara, California - an idyllic location offering immense natural beauty, outdoor adventure, big city amenities in a mid-sized town, and easy access to California's metropolitan centers.
Responsibilities
- Develop and implement quality assurance processes and procedures to monitor and evaluate the quality of medical devices.
- Establish and maintain documentation control processes to ensure accurate and up-to-date quality documentation.
- Review, approve, and maintain QMS records, including production history & lot release, training, supplier and technical report records.
- Review, approve, and maintain design control documentation, including design inputs, outputs, verification, and validation protocols/reports.
- Collaborate closely with cross-functional teams, including R&D, engineering, manufacturing, regulatory affairs, and clinical affairs, to ensure quality objectives are met throughout the product lifecycle.
- Investigate and analyze product non-conformances, complaints, and adverse events, and implement corrective and preventive actions (CAPAs) as necessary.
- Provide training and support to employees on quality management systems, regulatory requirements, and quality assurance processes.
- Evaluate, qualify and monitor suppliers and service providers to ensure they meet quality and regulatory requirements, and implement corrective actions as necessary to address any issues or deficiencies.
- Stay informed about changes in regulations, standards, and best practices in the medical device industry, and implement necessary updates to quality systems and processes.
Qualifications
- Humble, transparent, and embodying a team-first attitude.
- Reliable, meticulous, and hard-working.
- Independent, resourceful, and self-motivated.
- Strong analytical and problem-solving skills, with the ability to interpret complex technical information and regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
- Detail-oriented mindset with a focus on accuracy, thoroughness, and compliance with quality standards and regulations.
- Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology.
- Proficient computer skills including MS Word, PowerPoint, and Excel.
- Experience with electronic quality management systems (eQMS) and document control software is a plus.
Benefits
- Competitive compensation.
- Growth opportunities inherent to a fast-growing startup.
- 401K Plan with company matching.
- Medical insurance, including medical, dental, and vision coverage.
- Flexible paid time off.
- Immigration support.
Aptitude Medical Systems is an equal opportunity employer
and is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or any other consideration made unlawful by federal, state or local law.
